
[Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)]
[Rules and Regulations]
[Pages 43323-43329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17999]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0354; FRL-9930-84]


Sedaxane; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
sedaxane as a seed treatment for cotton, undelinted seed; cotton, gin 
byproducts; and beet, sugar. Syngenta Crop Protection, LLC requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective July 22, 2015. Objections and 
requests for hearings must be received on or before September 21, 2015, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0354, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs,

[[Page 43324]]

Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email 
address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0354 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
September 21, 2015. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2014-0354, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at  http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-
67), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
4F8263) by Syngenta Crop Protection, LLC, 410 Swing Road, P.O. Box 
18300, Greensboro, NC 27419. The petition requested that 40 CFR part 
180 be amended by establishing tolerances for residues of the fungicide 
sedaxane, N-[2-[1,1'-bicyclopropyl]-2-ylphenyl]-3-(difluoromethyl)-1-
methyl-1H-pyrazole-4-carboxamide, as a seed treatment for cotton, 
undelinted seed at 0.01 parts per million (ppm); cotton, gin byproducts 
at 0.01 ppm; and beet, sugar at 0.01 ppm. That document referenced a 
summary of the petition prepared by Syngenta Crop Protection, LLC, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
altered the commodity name from ``beet, sugar'' to ``beet, sugar, 
roots''. The reason for this change is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for sedaxane including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with sedaxane follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The toxicological effects reported in the submitted animal 
studies such as mitochondrial disintegration and glycogen depletion in 
the liver are consistent with the pesticidal mode of action also being 
the mode of toxic action in mammals. The rat is the most sensitive 
species tested, and the main target tissue for sedaxane is the liver. 
Sedaxane also caused thyroid hypertrophy/hyperplasia. In the acute 
neurotoxicity (ACN) and sub-chronic neurotoxicity (SCN) studies, 
sedaxane caused decreased activity, decreased muscle tone, decreased 
rearing, and decreased grip strength. There are indications of 
reproductive toxicity in rats such as decreased follicle counts, but 
these effects did not result in reduced fertility. Offspring effects in 
the reproduction study occurred at the same doses causing parental 
effects, and do not indicate any quantitative or qualitative increase 
in sensitivity in rat pups. In the rat, no adverse effects in fetuses 
were seen in developmental toxicity studies at maternally toxic

[[Page 43325]]

doses. In the rabbit, fetal toxicity (increased unossified sternebrae 
and 13th rudimentary ribs, decrease in fetal weights, increased numbers 
of abortions) was observed at the same doses that produced toxicity in 
the dams (abortions, decreased body weight gain/body weight loss, 
reduced food consumption, defecation), and therefore does not indicate 
any increased susceptibility. Sedaxane is tumorigenic in the liver in 
the rat and mouse, and led to tumors in the thyroid and uterus in the 
rat and was classified as ``likely to be carcinogenic to humans.'' 
Sedaxane was negative in the mutagenicity studies. The 28-day dermal 
study did not show systemic toxicity at the limit dose of 1,000 
milligrams/kilogram/day (mg/kg/day). Sedaxane has low acute toxicity by 
the oral, dermal, and inhalation routes. It is not a dermal sensitizer, 
causes no skin irritation and only slight eye irritation.
    Specific information on the studies received and the nature of the 
adverse effects caused by sedaxane as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Sedaxane. Human Health Risk 
Assessment to Support New Seed Treatment Uses on Cotton and Sugar 
Beet'' on pages 13-20 in docket ID number EPA-HQ-OPP-2014-0354.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors (U/SF) are used in conjunction 
with the POD to calculate a safe exposure level--generally referred to 
as a population-adjusted dose (PAD) or a reference dose (RfD)--and a 
safe margin of exposure (MOE). For non-threshold risks, the Agency 
assumes that any amount of exposure will lead to some degree of risk. 
Thus, the Agency estimates risk in terms of the probability of an 
occurrence of the adverse effect expected in a lifetime. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for sedaxane used for 
human risk assessment is shown in the Table of this unit.

    Table--Summary of Toxicological Doses and Endpoints for Sedaxane for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/Scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety  factors      risk  assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations,    NOAEL = 30 mg/kg/day  Acute RfD = 0.30 mg/ Rat ACN Study.
 including children and women 13-  UFA = 10x...........   kg/day.             LOAEL = 250 mg/kg based on reduced
 49 years of age).                 UFH = 10x...........  aPAD = 0.30 mg/kg/    activity, decreased rearing,
                                   FQPA SF = 1x........   day.                 initial inactivity, piloerection,
                                                                               ruffled fur and recumbency,
                                                                               decreased BW, decreased BWG and
                                                                               food consumption (males). In
                                                                               females, weakened condition,
                                                                               swaying gait, and decreased
                                                                               activity, reduced muscle tone,
                                                                               decreased locomotor activity and
                                                                               rearing. The weakened condition,
                                                                               swaying gait and decreased
                                                                               activity were observed on days 2-
                                                                               7, while the other effects were
                                                                               on day 1.
Chronic dietary (All populations)  NOAEL= 11 mg/kg/day.  Chronic RfD = 0.11   Chronic Rat Study.
                                   UFA = 10x...........   mg/kg/day.          NOAEL= 11/14 mg/kg bw/day (male/
                                   UFH = 10x...........  cPAD = 0.11 mg/kg/    female).
                                   FQPA SF = 1x........   day.                LOAEL = 67/86 mg/kg bw/day (male/
                                                                               female) based on decreased hind
                                                                               limb grip strength increased
                                                                               liver weight, increased
                                                                               incidences of hepatocyte
                                                                               hypertrophy and eosinophilic
                                                                               foci, and thyroid follicular cell
                                                                               hypertrophy, basophilic colloid,
                                                                               epithelial desquamation and
                                                                               increased phosphate levels
                                                                               (males). In females it was based
                                                                               on decreased body weight and body
                                                                               weight gain, increased liver
                                                                               weight and the same
                                                                               histopathology noted above for
                                                                               males.
Cancer (Oral, dermal, inhalation)   ``Likely to be Carcinogenic to Humans'' based on significant tumor increases
                                     in two adequate rodent carcinogenicity studies. Q1* = 4.64 x 10 - 3 (mg/kg/
                                                    day)-1 (linear low-dose extrapolation model).
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
  milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c
  = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
  Q1* = Linear cancer slope factor

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to sedaxane, EPA considered exposure under the petitioned-for 
tolerances as well as all existing sedaxane tolerances in 40 CFR 
180.665. EPA assessed dietary exposures from sedaxane in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for sedaxane. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA) conducted 
from 2003-2008. As to residue levels in

[[Page 43326]]

food, EPA conducted a highly conservative acute dietary assessment 
using tolerance-level residues and 100% crop treated assumptions for 
all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA conducted from 2003-2008. As to residue levels in food, EPA 
conducted a partially refined chronic dietary assessment using 
anticipated residue levels for all commodities and percent crop treated 
data.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that sedaxane should be classified as ``Likely to be 
Carcinogenic to Humans'' and a linear approach has been used to 
quantify cancer risk. Cancer risk was quantified using the same 
estimates as discussed in Unit III.C.1.ii., Chronic exposure. A linear 
low-dose extrapolation model (Q1*) = 4.64 x 10-3 
(mg/kg/day)-1 was used to estimate cancer risk.
    iv. Anticipated residue and percent crop treated (PCT) information.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT. The Agency estimated the PCT for 
existing uses as follows: For chronic and cancer dietary exposure 
assessment, 100 PCT was assumed for all commodities except for soybeans 
(51%), wheat (32%) and potato (67%), which incorporated average PCT 
estimates.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which sedaxane may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for sedaxane in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of sedaxane. Drinking water accounted for 95% of the 
total dietary exposure to sedaxane. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the FQPA Index Reservoir Screening Tool (FIRST) and 
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of sedaxane for acute exposures 
are estimated to be 4.1 parts per billion (ppb) for surface water and 
22.0 ppb for ground water, for chronic exposures and cancer assessments 
are estimated to be 1.2 ppb for surface water and 19.3 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 22.0 ppb was used to 
assess the contribution to drinking water. For chronic and cancer 
dietary risk assessment, the water concentration of value 19.3 ppb was 
used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Sedaxane is not 
registered for any specific use patterns that would result in 
residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA has not found sedaxane 
to share a common mechanism of toxicity with any other substances, and 
sedaxane does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that sedaxane does not have a common mechanism of 
toxicity with other substances. For information regarding

[[Page 43327]]

EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's Web site at http://www.epa.gov/pesticides/cumulative.

 D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA SF. In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence for 
increased susceptibility following prenatal and/or postnatal exposures 
to sedaxane based on effects seen in developmental toxicity studies in 
rabbits or rats. In range finding and definitive developmental toxicity 
studies in rats, neither quantitative nor qualitative evidence of 
increased susceptibility of fetuses to in utero exposure to sedaxane 
was observed. In these studies, there were no single-dose effects. 
There was no evidence of increased susceptibility in a 2-generation 
reproduction study in rats following prenatal or postnatal exposure to 
sedaxane. Clear NOAELs/LOAELs were established for the developmental 
effects seen in rats and rabbits as well as for the offspring effects 
seen in the 2-generation reproduction study. The dose-response 
relationship for the effects of concern is well characterized. The 
NOAEL used for the acute dietary risk assessment (30 mg/kg/day), based 
on effects observed in the ACN study, is protective of the 
developmental and offspring effects seen in rabbits and rats (NOAELs of 
100-200 mg/kg/day). In addition, there is no evidence of neuropathology 
or abnormalities in the development of the fetal nervous system from 
the available toxicity studies conducted with sedaxane.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for sedaxane is complete.
    ii. There is no indication that sedaxane is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity. Although sedaxane caused 
changes in apical endpoints such as decreased activity, decreased 
muscle tone, decreased rearing and decreased grip strength in the ACN 
and SCN studies, EPA believes these effects do not support a finding 
that sedaxane is a neurotoxicant. The observed effects in the ACN and 
SCN studies were likely secondary to inhibition of mitochondrial energy 
production caused by sedaxane. Furthermore, there was no corroborative 
neuro-histopathology demonstrated in any study, even at the highest 
doses tested (i.e., 2,000 mg/kg/day). Therefore, based on its chemical 
structure, its pesticidal mode of action, and lack of evidence of 
neuro-histopathology in any acute and repeated-dose toxicity study, 
sedaxane does not demonstrate potential for neurotoxicity. Since 
sedaxane did not demonstrate increased susceptibility to the young or 
specific neurotoxicity, a developmental neurotoxicity (DNT) study is 
not required.
    iii. As discussed in Unit III.D.2., there is no evidence that 
sedaxane results in increased susceptibility in in utero rats or 
rabbits in the prenatal developmental studies or in young rats in the 
2-generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments are highly 
conservative (acute) or only partially refined (chronic), resulting in 
high-end estimates of dietary food exposure. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to sedaxane in drinking water. These assessments 
will not underestimate the exposure and risks posed by sedaxane.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to sedaxane will occupy 1.3% of the aPAD for all infants (<1 year old), 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
sedaxane from food and water will utilize 1% of the cPAD for all 
infants (<1 year old), the population group receiving the greatest 
exposure. There are no residential uses for sedaxane.
    3. Short- and Intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short-term residential exposure 
plus chronic exposure to food and water (considered to be a background 
exposure level).
    A short- and intermediate-term adverse effect was identified; 
however, sedaxane is not registered for any use patterns that would 
result in short- or intermediate-term residential exposure. Short- and 
intermediate-term risk is assessed based on short- and intermediate-
term residential exposure plus chronic dietary exposure. Because there 
is no short- or intermediate-term residential exposure and chronic 
dietary exposure has already been assessed under the appropriately 
protective cPAD (which is at least as protective as the POD used to 
assess short-term risk), no further assessment of short- and 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short- and intermediate-term 
risk for sedaxane.
    4. Aggregate cancer risk for U.S. population. The Agency has 
classified sedaxane as ``Likely to be Carcinogenic to Humans'' based on 
significant tumor increases in two adequate rodent carcinogenicity 
studies. A cancer dietary risk assessment was conducted using a linear 
low-dose extrapolation model (Q1*) = 4.64 x 10-3 
(mg/kg/day)-1 which indicated a risk estimate to the U.S. 
population as 2 x 10-6. EPA generally considers cancer risks 
in the range of 10-6 or less to be negligible. The precision 
that can be assumed for cancer risk estimates is best described by 
rounding to the nearest integral order of magnitude on the log scale; 
for example, risks falling between 3 x 10-7 and 3 x 
10-6 are expressed as risks in the range of 10-6. 
Considering the precision with which cancer hazard can be estimated, 
the conservativeness of low-dose linear extrapolation, and the rounding 
procedure described above in this unit, cancer risk should generally 
not be assumed to exceed the

[[Page 43328]]

benchmark level of concern of the range of 10-6 until the 
calculated risk exceeds approximately 3 x 10-6. This is 
particularly the case where some conservatism is maintained in the 
exposure assessment. Based on this approach, EPA considers the risks of 
cancer from exposure to sedaxane to be negligible.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to sedaxane residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/tandem mass 
spectrometry (LC/MS/MS)) is available to enforce the tolerance 
expression. A modification of the Quick, Easy, Cheap, Effective, 
Rugged, and Safe (QuEChERS) method was developed for the determination 
of residues of sedaxane (as its isomers SYN508210 and SYN508211) in/on 
various crops. The sedaxane isomers (SYN508210 and SYN508211) are 
quantitatively determined by LC/MS/MS. The validated limit of 
quantitation (LOQ) reported in the method is 0.005 ppm for both 
sedaxane isomers. A successful independent laboratory validation (ILV) 
study was also conducted on the modified QuEChERS method using samples 
of wheat green forage and wheat straw fortified with SYN508210 and 
SYN508211 at 0.005 and 0.05 ppm. The analytical standard for sedaxane, 
with an expiration date of February 28, 2018, is currently available in 
the EPA National Pesticide Standards Repository.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established MRLs for sedaxane.

C. Revisions to Petitioned-For Tolerances

    Although the petitioner sought a tolerance for the commodity name 
``beet, sugar'', EPA is establishing a tolerance for ``beet, sugar, 
roots'' to be consistent with the general food and feed commodity 
vocabulary EPA uses for tolerances and exemptions.

V. Conclusion

    Therefore, tolerances are established for residues of sedaxane, N-
[2-[1,1'-bicyclopropyl]-2-ylphenyl]-3-(difluoromethyl)-1-methyl-1H-
pyrazole-4-carboxamide, as a seed treatment for cotton, undelinted seed 
at 0.01 ppm; cotton, gin byproducts at 0.01 ppm; and beet, sugar, roots 
at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: July 16, 2015.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

[[Page 43329]]

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.665, add alphabetically the following commodities to 
the table in paragraph (a) to read as follows:


Sec.  180.665  Sedaxane; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                                 Parts
                          Commodity                               per
                                                                million
------------------------------------------------------------------------
 
                                * * * * *
Beet, sugar, roots...........................................       0.01
 
                                * * * * *
Cotton, undelinted seed......................................       0.01
Cotton, gin byproducts.......................................       0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-17999 Filed 7-21-15; 8:45 am]
 BILLING CODE 6560-50-P


